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811 device results listed.

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D-R197133V

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197133V
Basic UDI-DI: B-R197133V
Reference: R19713
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-R197123T

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197123T
Basic UDI-DI: B-R197123T
Reference: R19712
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-R197113R

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197113R
Basic UDI-DI: B-R197113R
Reference: R19711
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-II Protein Induced by Vitamin K Absence or Antagonist-II (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-PIVKA-II706-AEF7
Basic UDI-DI: B-PIVKA-II706-AEF7
Reference: PIVKA-II706-AE10Y, PIVKA-II706-AE10N, PIVKA-II706-AE20Y, PIVKA-II706-AE20N
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 09:45

Manufacturer products Authorised representative products Authorised representative actors View details

NSE Neuron-Specific Enolase (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-NSE706-AE52
Basic UDI-DI: B-NSE706-AE52
Reference: NSE706-AE10Y, NSE706-AE10N, NSE706-AE20Y, NSE706-AE20N
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PIVKA-II CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PIVKA-II-05100C2
Basic UDI-DI: B-KR-PIVKA-II-05100C2
Reference: KR-PIVKA-II-05100
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PIVKA-II CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PIVKA-II-0250LA
Basic UDI-DI: B-KR-PIVKA-II-0250LA
Reference: KR-PIVKA-II-0250
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PIVKA-II CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PIVKA-II-02200BJ
Basic UDI-DI: B-KR-PIVKA-II-02200BJ
Reference: KR-PIVKA-II-02200
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX PIVKA-II CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-PIVKA-II-02100BD
Basic UDI-DI: B-KR-PIVKA-II-02100BD
Reference: KR-PIVKA-II-02100
EMDN: W0102039017
EMDN description: PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX NSE CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-NSE-01100C6M
Basic UDI-DI: B-KR-NSE-01100C6M
Reference: KR-NSE-01100C
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX LN CMIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-LN-01100CJK
Basic UDI-DI: B-KR-LN-01100CJK
Reference: KR-LN-01100C
EMDN: W0102039006
EMDN description: LAMININ
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:44

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX ß2-MG CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-B2-MG-01100CAV
Basic UDI-DI: B-KR-B2-MG-01100CAV
Reference: KR-β2-MG-01100C
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX AFP CMIA

KR-AFP-01100C

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-AFP-01100CPX
Basic UDI-DI: B-KR-AFP-01100CPX
Reference: KR-AFP-01100C
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-040P9

Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-040P9
Basic UDI-DI: B-K90411-040P9
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-032PA

Alpha-fetoprotein (AFP) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-032PA
Basic UDI-DI: B-K90411-032PA
Reference: /
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-K90411-017PE

Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-017PE
Basic UDI-DI: B-K90411-017PE
Reference: /
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407108JN

NSE Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407108JN
Basic UDI-DI: B-IM4407108JN
Reference: IM4407108
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4406108JF

NSE Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4406108JF
Basic UDI-DI: B-IM4406108JF
Reference: IM4406108
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403108HS

NSE Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403108HS
Basic UDI-DI: B-IM4403108HS
Reference: IM4403108
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402108HK

NSE Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402108HK
Basic UDI-DI: B-IM4402108HK
Reference: IM4402108
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details